EPIX Pharmaceuticals Inc., of Lexington, Mass., recently announced that it has reached agreement with the U.S. Food and Drug Administration on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic agent Vasovist.
From an action letter sent by the FDA, the MR contrast developer has received confirmation that the jointly agreed-upon protocol design and statistical analysis plan sufficiently addresses the objectives necessary to support the resubmission of the New Drug Application (NDA) for Vasovist, injectable intravascular contrast agent designed to provide visual imaging of the vascular system.
EPIX has initiated the re-read of images obtained in prior Phase 3 studies and expects to submit results in mid-2008.
"We are extremely pleased with the progress we have made with the FDA," said Andrew Uprichard, M.D., Ph.D., president and head of research and development at EPIX. "We have designed a protocol with input from the FDA that outlines the methodology of conducting the re-read of images and the statistical analysis of the data. As we announced in June 2007, the FDA has indicated that a blinded re-read of the images obtained from the previously completed Phase 3 clinical trials of Vasovist could support approval if the results meet the pre-specified endpoints agreed with the agency.”
